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Important Safety Information:

INDICATION:

DC Bead LUMI™ can be used as an embolic agent with or without delivery of doxorubicin or irinotecan. Unloaded DC Bead LUMI™ are intended to be used for the embolisation of non-malignant hypervascular tumours and arteriovenous malformations (AVMs).

For the use in malignant indications:

DC Bead LUMI™ are primarily intended as an embolic agent for the local treatment of malignant hypervascularised tumour(s) in the liver.

DC Bead LUMI™ are compatible with doxorubicin for the local treatment of tumours in patients with hepatocellular carcinoma (HCC). Doxorubicin can be loaded prior to embolisation and then as a secondary action, the beads will elute a local, controlled and sustained dose to the tumour after embolisation.

DC Bead LUMI™ are also intended to embolise the vessels supplying malignant colorectal cancer metastasised to the liver (mCRC).

DC Bead LUMI™ are compatible with irinotecan which can be loaded prior to embolisation and then as a secondary action, the beads will elute a local, controlled and sustained dose to the liver metastases from colorectal cancer after embolisation.

WARNING:

It is the doctor’s responsibility to give due consideration to the details in the drug product marketing authorisation in deciding which drug (either doxorubicin or irinotecan) to load DC Bead LUMI™ with and whether loading with that drug is appropriate for the patient under his/her care .The relevant Summary of Product Characteristics (SmPC) must be consulted. The type and dose of drug should also be assessed according to the individual patient’s clinical circumstances.